Advanced Malignant Solid Tumours
Conditions
Brief summary
This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
Interventions
DRUGSCTB41
SCTB41 of different doses,IV,every 3 weeks
Sponsors
Sinocelltech Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form (ICF); 2. Male or female, ≥18 years old; 3. Survival duration more than 3 months; 4. ECOG score ≤ 1 point; 5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour; 6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours; 7. Adequate organ and bone marrow function.
Exclusion criteria
1. Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases; 2. Other malignancies diagnosed; 3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment; 4. Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence; 5. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment; 6. Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study; 7. Significant coagulopathy or other evident risk of bleeding; 8. uncontrolled effusions in the serous cavities within 4 weeks before enrollment； 9. Major surgery or significant trauma within 4 weeks prior to enrollment;presence of unhealed skin wounds, surgical sites, trauma sites, severe- Page 3 of 4 \[DRAFT\] -mucosal ulcers, or fractures, or if the Investigator deems the participantunsuitable for the study; 10. History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs; 11. Known severe allergy to similar antibody drugs; 12. Presence of active infection； 13. History of organ transplantation or stem cell transplantation; 14. Pregnant or breastfeeding female; women of childbearing potential withpositive pregnancy test within 7 days before the enrollment; participants(including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting toxicity(DLT) | :From Day 0 up to Day 21 | Incidence of dose-limiting toxicities up to the Day 21 visit |
| Objective response rate (ORR) | Up to 2 years | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | Up to 2 years | The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1. |
| Progression-free survival (PFS) | Up to 2 years | Progression-free survival is defined as the time from the start of treatment with SCTB41 until the first documentation ofdisease progression or death due to any cause, whichever occurs first. |
| Overall survival (OS) | Up to 2 years | Overall survival is defined as the time from the start of treatment with SCTB41 until death due to any cause. |
Countries
China
Contacts
Primary Contactxiaoman zhang
Outcome results
None listed